CA2578419C

CA2578419C - Dialysis implant and methods of use

Info

Publication number: CA2578419C
Application number: CA2578419A
Authority: CA
Inventors: Daniel R. Burnett; Gregory W. Hall
Original assignee: Sequana Medical AG
Current assignee: Sequana Medical AG
Priority date: 2004-08-18
Filing date: 2005-08-17
Publication date: 2012-10-16
Anticipated expiration: 2025-08-17
Also published as: US9138523B2; CN101389373B; CA2578419A1; US8202248B2; EP1789109A2; US20160000984A1; CN101389373A; US20200054813A1; AU2005277459A1; US10398824B2; WO2006023589A2; WO2006023589A3; US20130218070A1; US20060058731A1; US11839712B2; AU2005277459B2; ES2441396T3; EP1789109B1; EP1789109A4

Abstract

A device and methods for treating renal failure are disclosed. One embodiment of the device is an implantable peritoneal dialysis device. When in use, the device can have a semi-permeable reservoir implanted in the peritoneal cavity.
The reservoir can receive blood waste and drain through one or more conduits, via a pump, to the biological bladder. Solids and/or a solution benefiting dialysis can be pumped to the reservoir and/or implanted in the peritoneal cavity.

Description

Daniel R. Burnett 6 Gregory Hall 9 1. Field of the Invention [00011 The present invention relates to an implantable device for drug delivery and 11 dialysis, particularly for peritoneal dialysis, and a method of using the system.

13 2. Description of the Related Art 14 [0002] Kidney failure is typically treated by dialysis until a kidney transplant or other treatment can replace the kidney function. Dialysis can be performed by 16 hemodialysis or peritoneal dialysis (PD).

17 100031 Hemodialysis treatment removes the blood from the body, often about 0.25 L
18 (8.5 fl. oz.) at a time, and often from a blood vessel in the arm. The extra-corporeal 19 blood is then passed through a semi-permeable membrane that removes the waste -including excess water - otherwise filtered by healthy kidneys, from the blood without 21 the loss of desirable molecules. Hemodialysis patients typically receive three 22 treatment sessions per week, with each session lasting 3 to 5 hours.
Because proper 23 maintenance of hemodialysis equipment (e.g., membranes, pumps) is critical, 24 hemodialysis sessions are often performed at a treatment center.

1 100041 PD treatment introduces a dialysis solution to the peritoneal cavity.
The 2 blood is naturally filtered through the organ membranes in the peritoneum.
Blood 3 waste naturally passes through the organ membranes in the peritoneal cavity.
The 4 waste is drawn into the peritoneal cavity by the osmotic pressure gradient created by the properly-formulated dialysis solution. After a few hours, the dialysis solution, 6 loaded with waste, can be removed. A patient can perform the "exchanges" of 7 dialysis solution at home, but must drain an extra-corporeal bag of dialysis solution 8 into the peritoneal cavity, and then drain their own peritoneal cavity into an extra-9 corporeal bag - all through a trans-peritoneum catheter. Patients also usually undergo four to six exchanges a day.

11 [0005] PD is widely considered to be a more effective treatment for removing waste 12 from the blood, but patients often prefer the relative infrequency and convenience of 13 hemodialysis. Most patients also prefer not to receive the large quantity and depth of 14 the punctures associated with PD.

[0006] U.S. Patent No. 5,037,385 to O'Byrne discloses an implantable peritoneal 16 dialysis system. The system includes an implanted trans-peritoneum catheter. The 17 trans-peritoneal catheter terminates outside the peritoneal cavity at a subcutaneous 18 self-sealing terminal structure and terminates inside the peritoneal cavity at an open 19 end. Dialysis solution can be introduced directly into the subcutaneous self-sealing terminal structure. The solution then flows into the peritonea] cavity. The system 21 also includes an implanted catheter that drains the peritoneal cavity into the bladder 22 via a pump.

23 [0007] The system disclosed by O'Byrne may reduce the number of times the 24 patient must drain their peritonea] cavity and may reduce the depth of the punctures needed to introduce dialysis solution to the peritoneal cavity. The system disclosed 1 by O'Byrne, however, fails to increases the number of painfiil punctures needed to 2 introduce the dialysis solution, fails to incorporate safeguards against pathologically 3 high pressures in the urinary bladder or pathologically low levels of peritoneal fluid, 4 fails to incorporate control mechanisms required for effective dialysis without dehydration, and fails to prevent loss of peritoneal proteins with extended use.
6 [0008] A need therefore exists for methods and devices for performing more 7 convenient and painless PD. There exists a need to reduce the frequency of punctures 8 patients receive during PD treatment. There also exists a need to reduce the depth of 9 punctures during PD therapy. Furthermore, there exists a need to fulfill the above needs without negatively affecting the quality of blood waste removal.

13 [0009] An implantable dialysis device is disclosed. In one embodiment of the 14 implantable dialysis, the device has two components: an implantable peritoneourinary pump system and an implantable dialysate infusion system.

16 100101 The implantable peritoneourinary pump system can have a first discharge 17 conduit for the withdrawal of peritoneal fluid from the peritoneal cavity.
The 18 implantable peritoneourinary pump system can have a peritoneourinary pump.
The 19 implantable peritoneourinary pump system can have a second discharge conduit. The second discharge (i.e., exit) conduit can shunt the fluid into the bladder.
The 21 implantable peritoneourinary pump system can have peritoneal and urinary pressure 22 sensors. The implantable peritoneourinary pump system can have a magnetically 23 coupled pump powering or recharging mechanism.

24 [0011] The first discharge conduit can be in fluid communication with the peritoneal cavity and the peritoneourinary pump. The first discharge conduit can have one or 1 more perforations. The perforations can allow for the influx of the peritoneal fluid.
2 The first discharge conduit can have a semi-permeable membrane or reservoir.
The 3 membrane or reservoir can restrict the flow of certain components of the peritoneal 4 fluid based on size and/or charge.

[0012] The peritoneourinary pump can be attached to the first and/or second 6 conduits. The peritoneourinary pump can be programmable and/or controllable via an 7 external signal generator. The peritoneourinary pump can be controlled as a function 8 of time. The peritoneourinary pump can be controlled through negative and/or 9 positive feedback loops, for example, using input from the pressure sensors.
100131 The second discharge conduit can be in fluid communication with the 11 peritoneourinary pump and the urinary bladder. The second discharge conduit can be 12 fixedly attached to the bladder wall. The second discharge conduit can be coated, for 13 example, to prevent encrustation.

14 [0014] The peritoneal and urinary pressure sensors can be loose in the peritoneal cavity and bladder, respectively, for example by being tethered but free-floating. The 16 peritoneal and urinary pressure sensors can be incorporated into the first and second 17 discharge conduits, respectively. The pressure sensors can be incorporated into the 18 peritoneourinary pump housing. The peritoneal and urinary pressure sensors control 19 the peritoneourinary pump in order to prevent excessive bladder pressure or abnormally low or high peritoneal pressure. The implantable dialysis device can also 21 have moisture, protein, strain (e.g., in the bladder wall), nerve sensors (e.g., to detect 22 nerve signals in the bladder, for example, to detect fullness), or combinations thereof.
23 [0015] The magnetically coupled pump powering mechanism can be used to directly 24 drive the peritoneourinary pump by the transdermally application of magnetic forces and/or to inductively recharge the internal battery. In one embodiment, for example 1 when the peritoneourinary pump is directly driven by magnetic forces, the first 2 discharge conduit can pass from the subcutaneous space into the peritoneal cavity.
3 The peritoneourinary pump can reside in the subcutaneous space. The second 4 discharge conduit can pass from the subcutaneous space into the bladder. The 5 subcutaneous location of the peritoneourinary pump can increase the applied strength 6 of magnetic forces used to drive the peritoneourinary pump.

7 [0016] In a second embodiment, for example when the internal battery is inductively 8 recharged, the implantable peritoneourinary pump system can be located anywhere in 9 the peritoneal, urinary or subcutaneous space. The inductive recharging coil can be located in close proximity to the skin, for example, to increase the effectiveness of 11 battery recharging.

12 [0017] When activated, the implantable peritoneourinary pump system can transfer 13 peritoneal fluid into the bladder via the first discharge conduit, the peritoneourinary 14 pump and the second discharge conduit. Peritoneal fluid transfer, for example through control of the peritoneourinary pump and/or valves, can be internally 16 controlled via negative or positive feedback from pressure sensors and/or externally 17 activated, for example, by a transdermal signal.

18 [0018] The implantable dialysate infusion system can elute concentrated dialysate, 19 other osmotic agents, or other therapeutic and/or diagnostic agents, or combinations thereof, into the peritoneal cavity. The eluting can be performed chronically.
The 21 implantable dialysate infusion system can have a reservoir. The implantable dialysate 22 infusion system can have a first transfer conduit. The implantable dialysate infusion 23 system can have an infusion pump. The infusion pump and the peritoneourinary 24 pump can be the same pump. The infusion pump and the peritoneourinary pump can 1 be separate pumps. The implantable dialysate infusion system can have a second 2 transfer conduit. The implantable dialysate infusion system can have a filling port.
3 [0019] The reservoir can be in fluid communication with the first transfer conduit 4 and the filling port. The reservoir can be made, in part or whole, from an impermeable material. The impermeable material can prevent or minimize undesired 6 leakage of dialysate into the peritoneal cavity. The implanted location of the reservoir 7 can allow for the accommodation of large volumes of concentrated solute inside the 8 reservoir. The reservoir can be located within the peritoneal cavity.

9 100201 The first transfer conduit can be in fluid communication with the reservoir and the infusion pump. The first transfer conduit can be absent from the implantable 11 dialysate infusion system, for example if the infusion pump is incorporated into the 12 reservoir.

13 100211 The infusion pump can be attached to the first and/or second transfer 14 conduits. The infusion pump can be incorporated into the implantable peritoneourinary pump system. The infusion pump can be programmable and/or 16 controllable via an external signal generator. The infusion pump can be controlled 17 through either negative or positive feedback loops using the pressure sensors of the 18 implantable peritoneourinary pump system. The infusion pump can be driven by 19 methods similar to methods'described supra for powering the peritoneourinary pump, for example, the infusion pump can be externally powered or rechargeable. The 21 infusion pump can be activated and deactivated in conjunction with the implantable 22 peritoneourinary pump system.

23 [0022] The second conduit can be in fluid communication with the infusion pump 24 and the peritoneal cavity. The second conduit, with one or more perforations, can function as the first conduit of the implantable peritoneourinary pump system 1 component of the device. The second conduit can terminate in a mixing chamber.

2 The mixing chamber can dilute the concentrated or solid dialysate with the peritoneal 3 fluid, for example, prior to discharge into the peritoneal cavity. Diluting and/or 4 mixing the concentrated or solid dialysate with the peritoneal fluid can prevent local reaction, for example a hyperosmotic reaction, to the mixed fluid.

6 [0023] The filling port can be in fluid communication with the reservoir.
The filling 7 port can be implanted in a position providing minimally invasive or percutaneous 8 access to the filling port. The filling port can have a self-sealing puncture membrane.
9 The filling port can have a locating mechanism, for example, a magnetic field or another signal generating mechanism. The filling port can be locatable via palpation.
11 [0024] When activated, the implantable dialysate infusion system can transfer 12 concentrated or solid dialysate from the reservoir into the peritoneal cavity, or mixing 13 chamber, via the first conduit, the infusion pump and the second conduit.
The 14 implantable dialysate infusion system can have slow-release formulation of concentrated dialysate in the form of a dialysate solid or concentrated solute.

16 [0025] A method of using the implantable dialysis device in an animal having a 17 peritoneal cavity and a bladder is disclosed. The method can include pumping 18 dialysate, or other osmotic or other agent, from the reservoir into the peritoneal cavity.
19 The method can include pumping some or all of the contents of the peritoneal cavity into the urinary bladder for evacuation, for example, after a time-delay from the 21 introduction of additional agents into the peritoneal cavity. The method can include 22 the percutaneous refilling of the reservoir. The method can include the use of timers 23 and pressure sensors to automatically administer peritoneal dialysis. The method can 24 minimize conscious patient interaction, for example, only requiring conscious patient 1 interaction for the refilling of the reservoir and the recharging or activating of the 2 pumps.

3 [0026] The implantable dialysate infusion system can be used to administer any 4 agent such as a drug, diagnostic, or therapeutic, for example, when large volumes of the agent are to be administered. Due to the implantable dialysate infusion system's 6 rechargeable nature, the implantable dialysate infusion system's ability to be refilled 7 and its large volume peritoneal reservoir, large amounts of drug or therapeutic could 8 be administered intravenously, subcutaneously or intraperitoneally over extended 9 periods of time with only infrequent puncture for refilling of the reservoir.

12 [0027] Figure 1 illustrates an embodiment of the implantable dialysis device.

13 100281 Figure 2 illustrates cross-section A-A of an embodiment of the distributor.
14 [0029] Figure 3 illustrates an embodiment of the implantable dialysis device.

100301 Figure 4 illustrates cross-section B-B of an embodiment of the distributor.
16 [0031] Figure 5 illustrates cross-section C-C of an embodiment of the distributor.
17 [00321 Figure 6 illustrates an embodiment of the implantable dialysis device.

18 [0033] Figure 7 illustrates cross-section D-D of an embodiment of the distributor.
19 [0034] Figure 8 illustrates an embodiment of the implantable dialysis device.

[0035] Figure 9 illustrates an embodiment of the exit conduit and the exit.

21 [0036] Figure 10 illustrates cross-section C-C of an embodiment of the distributor.
22 [0037] Figures 11-13 illustrate various embodiments of the implantable dialysis 23 device.

24 100381 Figures 14 and 15 illustrate various embodiments of the transfer element.

1 100391 Figure 16 illustrates a method and placement for implanting the implantable 2 dialysis device.

3 100401 Figures 17-22 illustrate an embodiment of a method for peritoneal dialysis 4 using the implantable dialysis device.

[0041] Figures 23-27 illustrate an embodiment of a method for peritoneal dialysis 6 using the implantable dialysis device.

7 [0042] Figures 28-32 illustrate various embodiments of a method for peritoneal 8 dialysis using the implantable dialysis device.

9 [0043] Figures 33 illustrates an embodiment of a method for using the implantable dialysis device having a mixing chamber.

11 [0044] Figures 34 illustrates an embodiment of a method for using the implantable 12 dialysis device having a inductive dipole transducer.

13 100451 Figure 35 illustrates an embodiment of a method for using the implantable 14 dialysis device implanted wholly in the peritoneal cavity and the bladder.

100461 Figure 36 illustrates an embodiment of a method for using the implantable 16 dialysis device with a first component and a second component.

19 100471 Figure 1 illustrates an implantable dialysis device 2. The implantable dialysis device 2 can have a distributor 4. The distributor 4 can be configured to 21 receive and distribute a dialysate and/or any other fluid or fluids, for example a 22 solution of therapeutic and or diagnostic agents. The dialysate can be received by the 23 distributor 4 and initially distributed through a reservoir conduit 6 to a reservoir 8. At 24 a later time, the distributor 4 can withdraw the dialysate from the reservoir 8 and distribute the dialysate through a discharge conduit 10 to a peritoneal cavity (shown 1 infra). At a later time, the distributor 4 can withdraw the dialysate and other waste 2. fluids and solids from the peritoneal cavity through the discharge conduit 10. The 3 distributor 4 can then distribute the withdrawn dialysate and waste fluids and solids 4 through the exit conduit 12 and out an exit 14 to a bladder (shown infra).

5 [0048] The distributor 4 can be attached to a reservoir conduit 6. The reservoir 6 conduit 6 can be attached to the reservoir 8. A reservoir connector 18 can attach the 7 reservoir conduit 6 to the reservoir 8. The reservoir 8 can be in fluid communication 8 with a reservoir conduit first end 20a. The reservoir connector 18 can reinforce the 9 attachment between the reservoir 8 and the reservoir conduit first end 20a.

10 [0049] The reservoir 8 can be a substantially or completely impermeable, leak-proof 11 container for indefinite storage of therapeutic and/or diagnostic fluids and/or solids.

12 The reservoir 8 can be hollow. A reservoir sensor 22, such as a reservoir pressure 13 sensor, reservoir pH sensor, reservoir temperature sensor, reservoir electrolyte sensor, 14 reservoir analyte sensor, or combinations thereof, can be attached to the inside of the reservoir 8.

16 [0050] The reservoir 8 can be substantially spherical, circular, cylindrical, tubular, 17 or have a shape similar to a partially flattened sphere. The reservoir 8 can be shaped 18 to fit in the negative space around organs, for example in the cul-de-sac of the 19 peritoneal cavity. The reservoir 8 can be made from at least two pieces of material.
The pieces of material can be joined at the perimeters of the pieces of material. The 21 pieces of material can be substantially circular.

22 [0051] The reservoir 8 can have a reservoir diameter 24. The reservoir diameter 24 23 can be from about 2 cm (0.8 in.) to about 20 cm (8 in.), more narrowly from about 4 24 cm (2 in.) to about 10 cm (4 in.), for example about 2 cm (0.8 in.), about 4 cm (2 in.), about 10 cm (4 in.), or about 20 cm (8 in.). The reservoir 8 can have a reservoir 1 volume. The reservoir volume can be from about 10 mL (0.6 in.3) to about 3000 mL

2 (200 in.), more narrowly from about 200 mL (10 in.3) to about 2000 mL (100 in.), 3 for example about 1500 mL (92 in.3). The reservoir volume can depend on the 4 potency (e.g., solute concentration) of the reservoir contents used with the reservoir 8.
100521 The reservoir 8 can be substantially impermeable, for example the outer 6 surface of the reservoir 8 can be made from a nonporous membrane or a membrane 7 with sufficiently small pores to minimize or prevent flow across the surface of the 8 reservoir 8.

9 [0053] The pore size can be dependent on the particle size of an agent (e.g., osmotic agent, dialysate) dispensed into the surrounding body cavity and/or tissue.
The pore 11 size can prevent leakage, for example, of particles with a molecular weight (MW) 12 from about 50 to about 5000, more narrowly a MW less than about 800, yet more 13 narrowly a MW from about 50 to about 100. The pores can be configured to exclude, 14 for example, sugars and dialysates (e.g., with a MW of about 800), synthetic osmotic agents (e.g., a MW of less than or equal to about 5000), glucose (e.g., about 2.27%

16 solution, MW of about 180.16), maltose, such as maltose disaccharide (e.g., about 17 4.32% solution, MW of about 342.30), maltotriose, such as maltotriose trisaccharide 18 (e.g., about 6.36% solution, MW of about 504.44), and maltopentaose, such as 19 maltopentaose pentasaccharide (e.g., about 10.4% solution, MW of about 828.72), any other osmotically active material, and combinations thereof.

21 [0054] The reservoir 8 can have pores having diameters substantially smaller than 22 about 500 m (19.7 mil), yet more narrowly from about 5 m (0.2 mil) to about 200 23 m (7.87 mil). ("Substantially smaller" can be having about 95% or more of the 24 pores being smaller.) The reservoir 8 can have an average pore diameter from about 5 m (0.2 mil) to about 500 m (1.97 mil), for example about 10 m (0.39 mil).
The 1 reservoir 8 can be made from any of the materials disclosed infra for all elements of 2 the implantable dialysis device 2. The reservoir 8 can be made from a biocompatible 3 impermeable membrane. The reservoir 8 can be made from, for example polymers, 4 such as polyacrylonitrile (PAN), polysulfone (PS), polyethersulfone, poluethylene, polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE) (e.g., TEFLONO, 6 E. I. Du Pont de Nemours and Company, Wilmington, DE), expanded PTFE (ePTFE) 7 (e.g., GORE-TEXO from W.L. Gore & Associates, Inc., Newark, DE), polyester 8 (e.g., DACRONO from E. I. Du Pont de Nemours and Company, Wilmington, DE), 9 polypropylene, polyether ether ketone (PEEK), Nylon, polyether-block co-polyamide polymers (e.g., PEBAX from ATOFINA, Paris, France), polyurethanes such as 11 aliphatic polyether polyurethanes (e.g., TECOFLEXO from Thermedics Polymer 12 Products, Wilmington, MA), polyvinyl chloride (PVC), thermoplastic, fluorinated 13 ethylene propylene (FEP), cellulose (e.g., VISKINGO> SERVAPORO> MEMBRA-14 CEL , or SPECTRA/PORO 1, 3 and 6 Dialysis Tubing from SERVA

Electrophoresis GmbH of Heidelberg, Germany; Cuprophane PT-150 from Enka-16 Glanstoff of Germany) such as a seamless regenerated cellulose and/or cellulose 17 acetate (CA), extruded collagen, silicone, a metal, such as single or multiple stainless 18 steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., 19 ELGILOYO; CONICHROME ), molybdenum alloys (e.g., molybdenum TZM
alloy), tungsten-rhenium alloys, or combinations of any of the above.

21 [0055] The reservoir 8, as well as other elements in contact with the stored fluids, 22 for example the elements from a filling port to the reservoir 8 and from the reservoir 8 23 to the distributor 4, can be made from strong and/or redundant materials having a 24 thickness and construction such that the material can remain intact without leaking or becoming substantially permeable during conditions of extreme acceleration, for 1 example in a halting car accident at about 89 km/h (55 miles per hour) producing, for 2 example, an acceleration of about 991.5 m/sz (3,253 f/s2).

3 100561 The reservoir 8 can be made from a multi-layer and/or fiber-reinforced 4 material. The reservoir 8 can be made from strong and redundant materials.
The reservoir 8 can be made from a flexible or rigid material.

6 [0057] The reservoir conduit 6 can be configured to enable the fluid communication 7 of dialysate or other fluid between the distributor 4 and the reservoir 8.
The reservoir 8 8 can be fixedly, removably and/or rotatably attached, directly or indirectly, to the 9 reservoir conduit first end 20a. The reservoir 8 can be in fluid communication with the reservoir conduit first end 20a. The distributor 4 can be attached to a reservoir 11 conduit second end 20b. The distributor 4 can be in fluid communication with the 12 reservoir conduit second end 20b.

13 100581 The reservoir conduit 6 can be flexible or rigid. The reservoir conduit 6 can 14 be deformable or resilient. The reservoir conduit 6 can be substantially impermeable.
[0059] The reservoir conduit 6 can have a reservoir conduit diameter 26 and a 16 reservoir conduit length 28. The reservoir conduit diameter 26 can be from about 1 17 mm (0.04 in.) to about 10 mm (0.4 in.), more narrowly from about 2 mm (0.08 in.) to 18 about 5 mm (0.2 in.), for example about 1 mm (0.04 in.), about 2 mm (0.08 in.), about 19 5 mm (0.2 in.), or about 10 mm (0.4 in.). The reservoir conduit length 28 can be from about 0 cm (0 in.) to about 50 cm (20 in.), more narrowly from about 5 cm (2 in.) to 21 about 20 cm (8 in.), for example about 5 cm (2 in.), about 10 cm (4 in.), about 20 cm 22 (8 in), or about 50 cm (20 in.).

23 [0060] The discharge conduit 10 can be configured to enable fluid communication 24 of dialysate, waste liquids and solids, and/or other fluid between the distributor 4 and the peritoneal cavity. The peritoneal cavity can be in fluid communication with a 1 discharge conduit first port 30 at a discharge conduit first end 32a. The distributor 4 2 can be attached to a discharge conduit second end 32b. The distributor 4 can be in 3 fluid communication with the discharge conduit second end 32b.

4 [0061] The discharge conduit 10 can be substantially impermeable, permeable, semi-permeable or combinations thereof. The discharge conduit first port 30 can have 6 an opening, and/or a permeable, and/or a semi-permeable surface. The discharge 7 conduit 10 can have multiple (not shown) discharge conduit first ports 30 that can be 8 at the discharge conduit first end 32a and/or along a discharge conduit length 34. The 9 discharge conduit first port 30 can be configured to minimize and/or prevent fluid communication of proteins, for example by size or charge exclusion (e.g., as 11 described in detail supra for the reservoir and infra for the transfer element and 12 barriers). A peritoneal cavity sensor 36, such as a peritoneal cavity pressure sensor, 13 peritoneal cavity pH sensor, peritoneal cavity temperature sensor, peritoneal cavity 14 electrolyte sensor, peritoneal cavity analyte sensor, or combinations thereof, can be attached to the discharge conduit 10, for example on or adjacent to the discharge 16 conduit first port 30.

17 100621 The discharge conduit 10 can have one or more perforations 38 along part or 18 all of the discharge conduit length 34. The perforations 38 can be along the discharge 19 conduit first end 32a and/or along the discharge conduit second end 32b.
The perforations 38 can be configured to allow the fluid communication of the dialysate or 21 other fluids. The perforations 38 can be configured to minimize and/or prevent fluid 22 communication of proteins for example by size or charge exclusion (e.g., as described 23 herein). The perforations 38 can be configured to minimize and/or prevent fluid 24 communication of dialysate solute.

1 [0063] The discharge conduit 10 can be flexible or rigid. The discharge conduit 10 2 can be deformable or resilient. The discharge conduit 10 can have a discharge 3 conduit diameter 40 and the discharge conduit length 34. The discharge conduit 4 diameter 40 can be from about 1 mm (0.04 in.) to about 10 mm (0.4 in.), more 5 narrowly from about 2 mm (0.08 in.) to about 5 mm (0.2 in.), for example about 1 mm 6 (0.04 in.), about 2 mm (0.08 in.), about 5 mm (0.2 in.), or about 10 mm (0.4 in.). The 7 discharge conduit length 34 can be from about 0 cm (0 in.) to about 50 cm (20 in.), 8 more narrowly from about 5 cm (2 in.) to about 20 cm (8 in.), for example about 5 cm 9 (2 in.), about 10 cm (4 in.), about 20 cm (8 in), or about 50 cm (20 in.).
The discharge 10 conduit 10 can be shaped to fit in the negative space around one or more organs 11 within the peritoneal cavity. The discharge conduit 10 can permit the inflow of bodily 12 fluids required to mix with dialysate fluid (e.g., in concentrated form) or solid 13 dialysate material prior to transfer into the peritoneal cavity.

14 [0064] The outer surface of the reservoir conduit 6 can be attached to the outer 15 surface of the discharge conduit 10 along the entire, part, or none of the reservoir 16 conduit length 28 and the discharge conduit length 34. The reservoir conduit 6 and 17 the discharge conduit 10 can share a common outer conduit (not shown) along the 18 entire or part of the reservoir conduit length 28 and the discharge conduit length 34.

19 The common outer conduit can be distinct or integral with the reservoir conduit 6 and/or the discharge conduit 10.

21 [0065] The exit conduit 12 can be configured to enable the fluid communication of 22 dialysate or other fluid between the distributor 4 and the bladder. The distributor 4 23 can be fixedly, removably and/or rotatably attached, directly or indirectly, to an exit 24 conduit first end 42a. The distributor 4 can be in fluid communication with the exit conduit first end 42a. The bladder (shown infra) can be attached to an exit conduit 1 second end 42b, for example by fixedly attaching an anchor 44 at the exit conduit 2 second end 42b against a wall of the bladder. For example, the anchor 44 can have a 3 flange that can form a one-way interference fit with the wall of the bladder. The 4 bladder, for example via an exit port 46, can be in fluid communication with the exit conduit second end 42b. A bladder sensor 48, such as a bladder pressure sensor, 6 bladder pH sensor, bladder temperature sensor, bladder electrolyte sensor, bladder 7 analyte sensor, or combinations thereof, can be attached to the exit conduit 12, for 8 example on or adjacent to the exit port 46.

9 [0066] The exit conduit 12 can be substantially impermeable (e.g., outside the bladder) and/or semi-permeable (e.g., inside the bladder) and/or permeable (e.g., 11 inside the bladder). The exit conduit 12 can be flexible or rigid. The exit conduit 12 12 can be deformable or resilient.

13 100671 The exit conduit 12 can have an exit conduit diameter 50 and an exit conduit 14 length 52. The exit conduit diameter 50 can be from about l mm (0.04 in.) to about 10 mm (0.4 in.), more narrowly from about 2 mm (0.08 in.) to about 5 mm (0.2 in.), 16 for example about 1 mm (0.04 in.), about 2 mm (0.08 in.), about 5 mm (0.2 in.), or 17 about 10 mm (0.4 in.). The exit conduit length 52 can be from about 0 cm (0 in.) to 18. about 50 cm (20 in.), more narrowly from about 5 cm (2 in.) to about 20 cm (8 in.), 19 for example about 5 cm (2 in.), about 10 cm (4 in.), about 20 cm (8 in), or about 50 cm (20 in.).

21 [0068] The exit conduit 12 can be distinct from the reservoir conduit 6 and/or the 22 discharge conduit 10. The exit conduit 12 can be integral with the reservoir conduit 6 23 and/or the discharge conduit 10. The exit conduit 12 can be in fluid communication 24 with the reservoir conduit 6 and/or the discharge conduit 10.

1 [0069] Any or all elements of the implantable dialysis device 2 can be made from, 2 for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., 3 Nitinol), cobalt-chrome alloys (e.g., ELGILOY(V from Elgin Specialty Metals, Elgin, 4 IL; CONICHROMEO from Carpenter Metals Corp., Wyomissing, PA), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub.
6 No. WO 03/082363 A2, published 9 October 2003), tungsten-rhenium alloys, for 7 example, as disclosed in International Pub. No. WO 03/082363, polymers such as 8 polyester (e.g., DACRONO from E. I. Du Pont de Nemours and Company, 9 Wilmington, DE), polypropylene, PTFE, ePTFE, PEEK, Nylon, polyether-block co-polyamide polymers (e.g., PEBAXO from ATOFINA, Paris, France), polyurethanes 11 such as aliphatic polyether polyurethanes (e.g., TECOFLEXO from Thermedics 12 Polymer Products, Wilmington, MA), PVC, PAN, PS, polyethersulfone, polyethylene, 13 polymethylmethacrylate (PMMA), thermoplastic, FEP, cellulose (e.g., VISKINGO, 14 SERVAPORO, MEMBRA-CELO, or SPECTRA/PORO 1, 3 and 6 Dialysis Tubing from SERVA Electrophoresis GmbH of Heidelberg, Germany; Cuprophane PT-150 16 from Enka-Glanstoff of Germany), such as a seamless regenerated cellulose and CA, 17 extruded collagen, silicone, echogenic, radioactive, radiopaque materials or 18 combinations thereof. Examples of radiopaque materials are barium sulfate, titanium, 19 stainless steel, nickel-titanium alloys, tantalum and gold.

[0070] Any or all elements of the implantable dialysis device 2 can be a matrix for 21 cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a 22 matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester 23 (e.g., DACRON from E. I. du Pont de Nemours and Company, Wilmington, DE), 24 polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof.

1 [00711 The elements of the implantable dialysis device 2 and/or the fabric can be 2 filled and/or coated with an agent delivery matrix known to one having ordinary skill 3 in the art and/or a therapeutic and/or diagnostic agent. The agents within these 4 matrices can include radioactive materials; radiopaque materials; cytogenic agents;
cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, 6 cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol;
7 lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for 8 example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 9 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRINO from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVILO from Wyeth, 11 Collegeville, PA; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXXO
12 from Merck & Co., Inc., Whitehouse Station, NJ; CELEBREXO from Pharmacia 13 Corp., Peapack, NJ; COX-1 inhibitors); immunosuppressive agents, for example 14 Sirolimus (RAPAMUNE , from Wyeth,, Collegeville, PA), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) 16 that act early within the pathways of an inflammatory response. Examples of other 17 agents are provided in Walton et al, Inhibition of Prostoglandin E2 Synthesis in 18 Abdominal Aortic Aneurysms, Circulation, July 6, 1999, 48-54; Tambiah et al, 19 Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline 21 by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J.

22 Surgery 86 (6), 771-775; Xu et al, Spl Increases Expression of Cyclooxygenase-2 in 23 Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589;
and 24 Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,.I. Clinical 1 Investigation 105 (11), 1641-1649 which are all incorporated by reference in their 2 entireties. The reservoir 8 can be made from any of the materials disclosed herein for 3 all elements of the implantable dialysis device 2. The reservoir 8 can be made from a 4 biocompatible impermeable membrane. The reservoir 8 can be made from, for example, silicone, cellulose (e.g., VISKING , SERVAPORO, MEMBRA-CELO, or 6 SPECTRA/PORO 1, 3 and 6 Dialysis Tubing from SERVA Electrophoresis GmbH of 7 Heidelberg, Germany; Cuprophane PT-150 from Enka-Glanstoff of Germany), such 8 as a seamless regenerated cellulose and CA, extruded collagen, silicone, polymers, 9 such as PAN, PS, polyethersulfone, polyether ether ketone (PEEK), Nylon, polyether-block co-polyamide polymers (e.g., PEBAXO from ATOFINA, Paris, France), 11 polyurethanes such as aliphatic polyether polyurethanes (e.g., TECOFLEX(&
from 12 Thermedics Polymer Products, Wilmington, MA), polyvinyl chloride (PVC), 13 poluethylene, polyester (e.g., DACRONO from E. I. Du Pont de Nemours and 14 Company, Wilmington, DE), polypropylene, PMMA, thermoplastic, fluorinated ethylene propylene (FEP), PTFE, and ePTFE, a metal, such as single or multiple 16 stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., 17 ELGILOYO; CONICHROMEO), molybdenum alloys (e.g., molybdenum TZM

18 alloy), tungsten-rhenium alloys, or combinations of any of the above.

19 [00721 The reservoir 8 can be made from an non-permeable material. The reservoir 8 can be made from a material having a thickness and construction such that the 21 material can remain intact without leaking or becoming substantially permeable 22 during conditions of extreme acceleration, for example in a halting car accident at 23 about 89 km/h (55 miles per hour) producing, for example, an acceleration of about 24 991.5 m/s2 (3,253 f/SZ). The reservoir 8 can be made from a multi-layer and/or fiber-reinforced material. The reservoir 8 can be made from a rigid material. The reservoir 1 8 can be made from any material listed herein, for example, polymers such as 2 polyester (e.g., DACRONO from E. I. Du Pont de Nemours and Company, 3 Wilmington, DE), polypropylene, polytetrafluoroethylene (PTFE) (e.g., TEFLONO, 4 E. I. Du Pont de Nemours and Company, Wilmington, DE), expanded PTFE (ePTFE) 5 (e.g., GORE-TEXO from W.L. Gore & Associates, Inc., Newark, DE), polyether 6 ether ketone (PEEK), Nylon, polyether-block co-polyamide polymers (e.g., PEBAX
7 from ATOFINA, Paris, France), polyurethanes such as aliphatic polyether 8 polyurethanes (e.g., TECOFLEXO from Thermedics Polymer Products, Wilmington, 9 MA), PVC, PAN, PS, polyethersulfone, polyethylene, PMMA, thermoplastic, FEP, 10 cellulose (e.g., VISKINGO, SERVAPORO, MEMBRA-CELO, or SPECTRA/PORO
l 1 1, 3 and 6 Dialysis Tubing from SERVA Electrophoresis GmbH of Heidelberg, 12 Germany; Cuprophane PT-150 from Enka-Glanstoff of Germany), such as a seamless 13 regenerated cellulose and/or CA, extruded collagen, silicone or combinations thereof.
14 [00731 The implantable dialysis device 2 can have one or more reservoir sensors 22.
15 The reservoir sensors 22 can be in the reservoir 8, and/or in the reservoir connector 16 18, and/or in the reservoir conduit 6. The reservoir sensors 22 can be configured to 17 measure pressure, pH, temperature, electrolyte concentration, analyte concentration, 18 or combinations thereof in the reservoir 8.

19 [0074] The implantable dialysis device 2 can have one or more peritonea]
cavity 20 sensors 36. The peritoneal cavity sensors 36 can be on the discharge conduit 10, for 21 examples, at the discharge conduit first end 32a and/or along the discharge conduit 22 length 34. The peritonea] cavity sensors 36 can be configured to measure pressure, 23 pH, temperature, electrolyte concentration, analyte concentration, or combinations 24 thereof in the peritoneal cavity.

1 [0075] The implantable dialysis device 2 can have one or more bladder sensors 48.

2 The bladder sensors 48 can be on the exit 14. The bladder sensors 48 can be 3 configured to measure pressure, pH, temperature, electrolyte concentration, analyte 4 concentration, or combinations thereof in the bladder. The sensors 22, 36, and 48 can measure concentration of dialysate solutes in the fluids. The sensors 22, 36, and 48 6 can send signals indicating respective measured metrics to the distributor 4.

7 [0076] Figure 2 illustrates that the distributor 4 can have a pump 54. The pump 54 8 can be a mechanical, electromechanical, osmotic or diffusion pump, or combinations 9 thereof. The pump 54 can be a hand-powered pump, for example the pump can be a resilient, compressible bulb pump. The pump 54 can be a miniature gear-pump.
The 11 pump 54 can be strong enough to clear clogs from the discharge conduit 10 and/or the 12 exit conduit 12. The pump 54 can produce a flow rate in the discharge conduit 10 13 from about 50 mL/min. (3.0 in.3/min.) to about 5000 mL/min. (300 in.3/min.), more 14 narrowly from about 250 mL/min. (15 in.3/min.) to about 500 mL/min. (30 in.3/min.).
The flow rate can be set to prevent bladder spasm with the rapid influx of the fluid.
16 [0077] The pump 54 can have and/or be in fluid communication with a distributor 17 valve 56 (shown infra). The distributor valve 56 can be a mechanical valve, a semi-18 permeable membrane or combinations thereof. The distributor valve 56 can be a 19 single, three-way valve.

100781 The distributor 4 can have a distributor first conduit 58a. The distributor first 21 conduit 58a can be in fluid communication with the reservoir conduit second end 20b.
22 The distributor first conduit 58a can be in fluid communication with the distributor 23 valve 56. The distributor first conduit 58a can be integral with the reservoir conduit 24 second end 20b.

1 100791 The distributor 4 can have a distributor second conduit 58b. The distributor 2 second conduit 58b can be in fluid communication with the discharge conduit 10.

3 The distributor second conduit 58b can be in fluid communication with the distributor 4 valve 56. The distributor second conduit 58b can be integral with the discharge conduit 10.

6 100801 The distributor 4 can have a distributor third conduit 58c. The distributor 7 third conduit 58c can be in fluid communication with the exit conduit first end 42a.
8 The distributor third conduit 58c can be in fluid communication with the distributor 9 valve 56. The distributor third conduit 58c can be integral with the exit conduit first end 42a.

11 [0081] The distributor valve 56 can be configured to route flow between a 12 distributor first conduit 58a, the distributor second conduit 58b, and the distributor 13 third conduit 58c. The distributor valve 56 can be configured as a one-way flow or 14 check valve, for example, preventing backflow in any direction. The distributor valve 56 can be a one-way valve preventing flow in the direction from the distributor third 16 conduit 58c to either the distributor first conduit 58a or the distributor second conduit 17 58b.

18 [0082] The distributor valve 56 can be a pressure sensing valve. The distributor 19 valve 56 can be configured to shut off flow if backpressure exceeds a pre-determined threshold. If pressure in the peritoneal cavity is less than about 1.5 kPa (0.15 psi), 21 more narrowly less than about I kPa (0.1 psi), yet more narrowly less than about 0.5 22 kPa (0.07 psi), then the pump 54 can be inhibited (e.g., stopped or slowed), for 23 example be the distributor valve 56 and/or a controller. If the absolute pressure in the 24 bladder is greater than or equal to about 3 kPa (0.4 psi), more narrowly, greater than or equal to about 4 kPa (0.6 psi), then the pump 54 can be inhibited. If the differential 1 between the pressure in the peritoneal cavity and the pressure in the bladder pressure 2 is greater than or equal to about 2 kPa (0.3 psi), more narrowly greater than or equal 3 to about 3 kPa (0.4 psi), then the pump 54 can be inhibited.

4 [0083] The distributor 4 can have a power storage and/or regulation device, for example a battery 60. The battery 60 can be configured to supply power to the pump 6 54 and/or the distributor valve 56. The battery 60 can be one or more power storage 7 devices (not shown), for example capacitors, dry or wet cells, flywheels, springs, or 8 combinations thereof. The battery 60 can hold a charge of more than about 500 mAh, 9 for example about 1000 mAh. For example 3 AA Nickel Cadmium about 1000 mAh batteries can be used. The battery 60 can be configured to provide a current of greater 11 than about 0.2 DCA and/or less than about 2.0 DCA, for example about 0.42 DCA.

12 [0084] The distributor 4 can have an internal transducer 62. The internal transducer 13 62 can receive energy in a first form (e.g. moving magnetic fields), convert the energy 14 into a second form (e.g., direct current electricity), and deliver the second form of energy to appropriate elements (e.g., pump 54, distributor valve 56, controller) in the 16 implantable dialysis device 2. The internal transducer 62 can be wholly or partially 17 inside a distributor case. An internal transducer connector 64 (shown infra) can be 18 configured to deliver the energy to the appropriate elements. The internal transducer 19 connector 64 can be wholly within the distributor case.

[0085] The distributor 4 can have an internal filling port 66. The internal filling port 21 66 can have a self-sealing membrane forming at least part of the external wall of the 22 distributor 4. The internal filling port 66 can be configured to receive injections (e.g., 23 of dialysate solution and/or other agent), for example from a transcutaneous needle.
24 The internal filling port 66 can have a locating mechanism, for example, a magnetic field or another signal generating mechanism. The locating mechanism can aid 1 targeting the internal filling port 66, for example, when injecting dialysate solution 2 and/or other agent. The internal filling port 66 can have a storage volume.
The 3 internal filling port 66 can have a non-corrosive internal surface. The internal filling 4 port 66 can be a receptacle for a cartridge or ampoule. A filling conduit 68 can be configured to create fluid communication between the internal filling port 66 and the 6 reservoir conduit 6.

7 [0086] Figure 3 illustrates the implantable dialysis device 2 that can have a first 8 component 72a and a second component 72b. The first component 72a can be 9 physically unattached to the second component 72b.

[0087] The first component 72a can be configured to pump fluid from a drainage 11 conduit 74 to, and out, the exit conduit 12. The drainage conduit 74 can have a 12 drainage conduit first port 75. The first component 72a can have a first distributor 4a.
13 The first distributor 4a can be attached to the drainage conduit 74. The first 14 distributor 4a can be attached to the exit conduit 12.

100881 The second component 72b can be configured to receive a solution, for 16 example, dialysate by injection into a second distributor 4b. The second component 17 72b can be configured to deliver and store the solution in the reservoir 8.
The second 18 component 72b can be configured to deliver the stored solution from the reservoir 8 19 to, and out, the discharge conduit 10.

[0089] The second distributor 4b can be attached to the reservoir conduit 6 and the 21 reservoir 8. The second distributor 4b can be attached to the discharge conduit 10.
22 [0090] The first component 72a can be in data and/or power communication with 23 the second component 72b. One or more wires (not shown) can attach the first 24 component 72a to the second component 72b. The first component 72a can communicate with the second component 72b over a data network, for example, a 1 wired and/or wireless network, such as Ethernet (IEEE 802.3), Firewire (IEEE
1394), 2 802.11 (wireless LAN), Bluetooth, cellular communication, serial port (RS-232, RS-3 485), parallel port (IEEE 1284), Fiber Channel, IRDA infrared data port, radio such as 4 900 MHz RF or FM signal, or combinations thereof.

5 [0091] Any implantable dialysis device 2 can also use the communication networks 6 supra to communicate data with an extracorporeal component, for example, a 7 monitoring device such as a handheld diagnostic computer or peripheral device (e.g., 8 a personal data assistant). The extracorporeal component can transmit and receive 9 data and/or energy from the implantable dialysis device 2 (e.g., from the internal 10 transducer 62 and/or controller and/or battery 60). The extra corporeal component 11 can be used to control operation of, or provide an energy charge to, the implantable 12 dialysis device 2.

13 100921 Figure 4 illustrates the first distributor 4a that can have no internal filling 14 port 66. The first distributor 4a can have no distributor third conduit 58c. The 15 exterior of the distributor 4 can be the distributor case 76. The distributor case 76 can 16 be made from, coated, or otherwise surrounded with a biocompatible material.

17 [0093] The distributor 4 can have a distributor first port 78a and a distributor second 18 port 78b. The distributor ports 78a and 78b can be voids in the distributor case 76, 19 semi-permeable membranes, permeable membranes, or combinations thereof. The 20 distributor first port 78a can be fixedly or releasably attached to a conduit, for 21 example, the drainage conduit 74. The distributor second port 78b can be fixedly or 22 releasably attached to a conduit, for example the exit conduit 12.

23 [0094] A distributor first port 78a can be fixedly or releasably attached to and/or 24 integral with, and in fluid communication with, the drainage conduit 74. A
distributor 25 second port 78b can be fixedly or releasably attached to and/or integral with, and in 1 fluid communication with, the exit conduit 12. The distributor valve 56 can be a one-2 way check valve permitting flow from the distributor first port 78a to the distributor 3 second port 78b, but preventing or minimizing flow from the distributor second port 4 78b to the distributor first port 78a.

100951 The internal transducer 62 can be outside the distributor case 76. The 6 internal transducer 62 can be an induction coil. The internal transducer connector 64 7 can connect the internal transducer 62 to the pump 54 and/or to one or more power 8 storage devices (not shown), for example capacitors, dry or wet cells, flywheels, 9 springs, or combinations thereof. The internal transducer connector 64 can pass through the distributor case 76.

11 [00961 For implantable dialysis devices 2 that have more than one distributor 4, any 12 or each distributor 4 can have a separate pump 54.

13 100971 Figure 5 illustrates that the second distributor 4b can have the storage 14 volume of the internal filling port 66 surrounding the pump 54. The distributor case 76 can be a self-sealing material configured to allow a needle puncture in one or more 16 locations.

17 [0098] The reservoir conduit second end 20b (not shown) can be fixedly or 18 releasably attached to and/or integral with, and in fluid communication with, the 19 distributor first port 78a. The discharge conduit second end 32b (not shown) can be fixedly or releasably attached to and/or integral with, and in fluid communication 21 with, the distributor second port 78b.

22 [00991 Figure 6 illustrates the implantable dialysis device 2 that can have a first 23 discharge conduit l0a and a second discharge conduit I Ob. The first and second 24 discharge conduits I Oa and I Ob can have first and second discharge conduit lengths 34a and 34b and first and second discharge conduit diameters 40a and 40b that can be 1 equivalent to those supra for the discharge conduit 10. The first and/or second 2 discharge conduits l0a and/or l Ob can have first and/or second peritoneal cavity 3 sensors 36a and/or 36b, respectively.

4 101001 The first and/or second discharge conduits 10a and/or I Ob can have a first and/or second discharge conduit first port guards 80a and/or 80b. The guards 80a and 6 80b can be rigid, semi-rigid or flexible. The port guards 80a and 80b can be wire 7 screens, permeable membranes, or combinations thereof The port guards 80a and 8 80b can be configured to filter particles based on size and/or charge.

9 [0101] Figure 7 illustrates that the distributor 4 can have the distributor first conduit 58a, the distributor second conduit 58b, and the distributor third conduit 58c that can 11 be segmented from a single channel, and/or be adjacent to each other. The distributor 12 first, second, and third conduits 58a, 58b and 58c can all open on the same side of the 13 distributor 4. The distributor 4 can have a distributor fourth conduit 58d.
The 14 distributor fourth conduit 58d can open on a different side of the distributor 4 than the first, second and third conduits 70a, 70b and 70c.

16 [0102] The reservoir conduit second end 20b can be fixedly or releasably attached to 17 and/or integral with, and in fluid communication with, the distributor first conduit 18 58a. The first discharge conduit second end 32b' can be fixedly or releasably 19 attached to and/or integral with, and in fluid communication with, the distributor second conduit 58b. The second discharge conduit second end 32b can be fixedly or 21 releasably attached to and/or integral with, and in fluid communication with, the 22 distributor third conduit 58c. The fourth conduit 58d can be fixedly or releasably 23 attached to and/or integrated with, and in fluid communication with, the exit conduit 24 12.

1 [0103] Figure 8 illustrates that the implantable dialysis device 2 can have the first 2 and second distributors 4a and 4b. The reservoir conduit 6 can have an inflow 3 channel 86 and an outflow channel 88.

4 [01041 The inflow and outflow channels 86 and 88 can be separated by a septum, be otherwise attached or integral, or be contained within two distinct, and separate tubes.
6 The inflow channel 86 can be attached to the outflow channel 88 along part or all of 7 the lengths of the inflow channel 86 and the outflow channel 88.

8 [0105] The inflow channel 86 can provide fluid communication between the 9 internal filling port 66 and the reservoir 8. The internal filling port 66 and/or filling conduit (not shown in Figure 8) can be attached to the inflow channel 86. The 11 reservoir 8 and/or the reservoir connector 18 can be attached to the inflow channel 86.
12 The inflow channel 86 can be attached to and/or integral with the reservoir 8 and the 13 second distributor 4b, for example with the internal filling port 66. The inflow 14 channel 86 can be in direct fluid communication with, and/or attached to, the first distributor 4a. The first distributor 4a can be configured to provide a positive and/or 16 negative pressure to the inflow channel 86.

17 101061 The outflow channel 88 can be in direct fluid communication with, and 18 attached to and/or integral with the first distributor 4a and the reservoir 8 and/or the 19 reservoir connector 18.

101071 The discharge conduit 10 can have one or more perforations 38 along part or 21 all of the discharge conduit length 34. The perforations 38 can be along the discharge 22 conduit first end 32a and/or along the discharge conduit second end 32b.
The 23 perforations 38 can be configured to allow the fluid communication of dialysate 24 solute. The perforations 38 can be configured to disallow fluid communication of 1 proteins. The perforations 38 can be configured to disallow fluid communication of 2 dialysate solute.

3 [01081 The first distributor 4a can have the pump 54 (not shown). The second 4 distributor 4b can have the internal filling port 66. The second distributor 4b can have the internal transducer 62. The internal transducer connector 64 can be attached to the 6 first distributor 4a and/or the second distributor 4b. The internal transducer connector 7 64 can transfer power from the second distributor 4b to the first distributor 4a. The 8 first and/or second distributors 4a and/or 4b can have the batteries 60 (not shown in 9 Figure 8).

101091 Figures 8 and 9 illustrate that the exit conduit 12 can have an exit extension 11 90. The exit extension 90 can be semi-permeable, permeable, impermeable, or 12 combinations thereof. The exit extension 90 can have a length of conduit, for 13 example a coiled or "pigtail" catheter. The exit extension 90 can have one or more 14 exit ports 46. The exit extension 90 can have an exit tip 94. The exit tip 94 can have the exit port 46 (not shown in Figures 8 or 9). The exit tip 94 can be semi-permeable, 16 impermeable, permeable, or combinations thereof.

17 [0110] The exit conduit 12 can have an exit conduit longitudinal axis 96.
The exit 18 conduit 12 can have one or more sub-anchors 98. The sub-anchors 98 can be 19 substantially perpendicular to the exit conduit longitudinal axis 96. The anchor 44 can be substantially perpendicular to the exit conduit longitudinal axis 96.
The sub-21 anchors 98 can be flanges. The sub-anchors 98 can be rigid or flexible.

22 101111 Figure 10 illustrates that the pump 54 can have or be mechanically attached 23 to a rotational electromechanical motor 99. The motor 99 can be configured to be 24 inductively driven. The motor 99 can have a first pole 100a and a second pole 100b.
A pole axle 102 can attach the first pole 100a to the second pole 1 OOb. The pole axle 1 102 can rotate about a motor rotation axis 104, for example when the first and second 2 poles 100a and 100b are urged by a dynamic external magnetic field. The pole axle 3 102 can be mechanically coupled to a flow driving mechanism (not shown). The 4 pump 54 and/or motor 99 can be the taught by PCT Patent Application titled 5 Magnetic Circumferentially Coupled Implantable Pump, filed 18 August 2004 6 (attorney docket number TN 1004-PCT), and hereby incorporated by reference in its 7 entirety.

8 [01121 Figures 11 through 13 (not showing elements of the implantable dialysis 9 device 2 for clarity) illustrate various configurations of the peritoneal cavity sensor 36 10 and bladder sensor 48. The peritonea] cavity sensor 36 and bladder sensor 48 can be 11 in fluid communication with the discharge conduit 10 and/or exit conduit 12, 12 respectively (i.e., and the peritoneal cavity and the bladder, respectively, during use).
13 As shown in Figure 11, the peritoneal cavity sensor 36 and bladder sensor 48 can be 14 attached to the discharge conduit 10 and exit conduit 12. The peritoneal cavity sensor 15 36 and the bladder sensor 48 can be on the inside (as shown) and/or outside of the 16 discharge and exit conduits 10 and 12. As shown in Figure 12, the peritoneal cavity 17 sensor 36 and bladder sensor 48 can be located in the distributor 4. As shown in 18 Figure 13, the peritoneal cavity sensor 36 can be attached to a peritoneal tether 106.
19 The bladder sensor 48 can be attached to a bladder tether 108. Multiple sensors 36 20 and 48 can be attached to each tether 106 and 108. The tethers 106 and 108 can be 21 attached to the respective conduits 10 and 12, and/or the distributor 4, and/or to other 22 elements of the implantable dialysis device 2. The tethers 106 and 108 can be flexible 23 or rigid.

1 [01131 The implantable dialysis device 2 can have more than_one of each peritoneal 2 cavity sensor 36 and bladder sensor 48. The peritoneal cavity sensor 36 and bladder 3 sensor 48 can be in any combination of configurations.

4 101141 Figures 14 and 15 illustrate that the implantable dialysis device 2 can have a transfer element 110 at the first end of the drainage (e.g., shown without the transfer 6 element 110 in Figure 3) and/or discharge (e.g., shown without the transfer element 7 110 in Figure 6) conduits 74 and/or 10. The transfer element 110 can be integral with, 8 and/or attached to, the conduits 74 and/or 10 via a transfer element connector 111.

9 The transfer element l 10 can have a permeable surface. The transfer element 110 can be configured to filter peritoneal fluids across a transfer element face 112.
The 11 transfer element 110 can be configured to filter fluid across the transfer element face 12 112 through size and/or charge exclusion. The transfer element 110 can be 13 configured to allow water and waste in the peritoneal fluid to osmotically transfer into 14 the transfer element 110.

10115J Figure 14 illustrates that the transfer element 110 can be configured to 16 resiliently expand and compress, as shown by arrows. The transfer element 110 can 17 be configured to transfer liquids out of the transfer element 110 and into the drainage 18 and/or discharge conduits 74 and/or 10. The transfer element 110 can be biased to 19 stay in an expanded configuration at rest. The transfer element 110 can be hollow.
The hollow inside the transfer element 110 can be in fluid communication with the 21 drainage and/or discharge conduits 74 and/or 10. A one-way valve (not shown) in the 22 drainage and/or discharge conduits 74 and/or 10, the transfer element connector 111, 23 or the transfer element 110, can be configured to prevent or minimize fluid 24 communication from the drainage and/or discharge conduits 74 and/or 10 to the 1 reservoir 8. The transfer element 110 can have a substantially cylindrical 2 configuration.

3 [01161 The transfer element 110 can have a transfer element face 112. The transfer 4 element 110 can have two or more transfer element faces 112. The transfer element faces 112 can be made from a substantially impermeable, semi-permeable, permeable 6 material, or combinations thereof. The transfer element face 112 can be configured to 7 be substantially or wholly permeable to dialysate solutes. The transfer element face 8 112 can be substantially or wholly impermeable to proteins. The transfer element 9 face 112 can be made from the materials listed herein, for example, polyester (e.g., DACRON from E. I. Du Pont de Nemours and Company, Wilmington, DE), 11 polypropylene, PTFE (e.g., TEFLON , E. I. Du Pont de Nemours and Company, 12 Wilmington, DE), ePTFE (e.g., GORE-TEX from W.L. Gore & Associates, Inc., 13 Newark, DE), PEEK, Nylon, polyether-block co-polyamide polymers (e.g., PEBAX(M
14 from ATOFINA, Paris, France), polyurethanes such as aliphatic polyether polyurethanes (e.g., TECOFLEX from Thermedics Polymer Products, Wilmington, 16 MA), polyvinyl chloride (PVC), PAN, PS, polyethersulfone, polyethylene, PMMA, 17 thermoplastic, FEP, cellulose (e.g., VISKING , SERVAPOR , MEMBRA-CEL , 18 or SPECTRA/POR 1, 3 and 6 Dialysis Tubing from SERVA Electrophoresis GmbH
19 of Heidelberg, Germany; Cuprophane PT-150 from Enka-Glanstoff of Germany), such as a seamless regenerated cellulose and CA, extruded collagen, silicone, 21 echogenic, radioactive, radiopaque materials or combinations thereof. Any of the 22 polymers can be permeable if woven loosely enough, as known to those having 23 ordinary skill in the art.

24 [01171 The transfer element faces 112 can be made from a porous membrane.
The transfer element faces 112 can have pores having diameters substantially smaller than 1 about 500 m (19.7 mil), yet more narrowly from about 5 m (0.2 mil) to about 200 2 m (7.87 mil). ("Substantially smaller" is having about 95% or more of the pores 3 being smaller.) The transfer element faces 112 can have an average pore diameter 4 from about 5 m (0.2 mil) to about 500 m (1.97 mil), for example about 10 m (0.39 mil). The transfer element faces 112 can contain pores having diameters less than 6 about 10 mm (0.4 in.), more narrowly less than about 5 mm (0.2 in.). For example 7 the pores can have diameters less than about 2 mm (0.08 in.), more narrowly less than 8 about 1 mm (0.04 in.), yet still more narrowly less than about 0.5 mm (0.02 in.). For 9 example the pores can have diameters of about 2 mm (0.08 in.).

101181 The transfer element 110 can have a transfer element side 114. The transfer 11 element side 114 can be made from a substantially impermeable, semi-permeable, 12 permeable material, or combinations thereof. The transfer element side 114 can be 13 configured to be substantially or wholly permeable to dialysate solutes.
The transfer 14 element side 114 can be substantially or wholly impermeable to proteins.
The transfer element sides 114 can be made from a material that has a permeability that is not 16 substantially effected by expansion and contraction. The transfer element side 114 17 can be made from materials listed herein, for example the materials listed for the 18 transfer element faces 112.

19 [0119] The transfer element side 114 can be made from one or more material listed infra for making the transfer element faces 112.

21 101201 The transfer element 110 can have one or more transfer element frames 116.
22 The frames 116 can be wires or filaments. The frames 116 can be rigid, flexible, 23 resilient, deformable, or combinations thereof. The frames 116 can be made from, for 24 example, Nitinol or stainless steel. The frames 116 can be circular, oval, triangular, square, pentagonal, hexagonal, or combinations thereof. The frames 116 can be on 1 the outside of, the inside of, embedded into, or any combination thereof with, the 2 material on the surface of the transfer element 110.

3 [01211 The transfer element side 114 can have one or more bellows 1] 8. The 4 transfer element side 114 can have about three bellows 118. The bellows 118 can be covered by a flexible material. Each bellow 118 can have one frame 116 on each side 6 of the bellow 118.

7 [01221 The transfer element 110 can have one or more struts 120. The struts 8 can provide resiliency to the transfer element 110. When the transfer element 110 is 9 in the expanded configuration, the struts 120 can be fully extended and/or straight or slightly curved. The struts 120 can attach a first frame 116a to a second frame 116b.
11 One strut 120 can attach to all of the frames 116. One strut 120 can attach to the 12 frame 116 on a first transfer element face 112 and the frame 116 on a second transfer 13 element face 112.

14 [01231 The transfer element l 10 can be resilient. During use, the resiliency of the transfer element 110 can produce a slow and steady negative pressure in the 16 peritoneal cavity. The negative pressure can be from about -500 mmHg (-10 psi) to 17 about -5 mmHg (-0.1 psi), more narrowly from about -300 mm Hg (-6 psi) to about -18 50 mmHg (-1 psi), for example -500 mmHg (-10 psi), about -300 mm Hg (-6 psi), 19 about -50 mmHg (-1 psi), or about -5 mmHg (-0.1 psi).

[01241 The transfer element 110 can have a transfer element height 124. The 21 transfer element height 124 can be from about 0 cm (0 in.) to about 8 cm (3 in.), more 22 narrowly from about 1 cm (0.4 in.) to about 4 cm (2 in.), for example about 0 cm (0 23 in.), about 1 cm (0.4 in.), about 2 cm (0.8 in.), about 4 cm (2 in.), or about 8 cm (3 24 in.).

1 [01251 The transfer element 110 can have a transfer element radius 126. The 2 transfer element radius 126 can vary over the transfer element height 124.
The 3 transfer element radius 126 can be from about 1 cm (0.4 in.) to about 10 cm (4 in.), 4 more narrowly from about 2 cm (0.8 in.) to about 4 cm (2 in.), for example about 1 5 cm (0.4 in.), about 2 cm (0.8 in.), about 4 cm (2 in.), or about 10 cm (4 in.).

6 [0126] Figure 15 illustrates that the reservoir can have a first barrier 128a and/or a 7 second barrier 128b. The transfer element 110 can have more than two barriers 128.
8 The barriers 128 can have barrier sides 130. The barrier sides 130 can be rigid or 9 flexible. The barriers 128 can have barrier faces 132. The barrier faces 132 can be 10 supported away from the transfer element faces 112, for example, by the barrier sides 11 130. The barrier faces 132 can be in contact with the transfer element faces 112.

12 [0127] The barriers 128 can be made from a substantially impermeable, semi-13 permeable, permeable material, or combinations thereof. The barriers 128 can be 14 configured to be substantially or wholly permeable to dialysate solutes.
The barriers 15 128 can be substantially or wholly impermeable to proteins. The barriers 128 can be 16 made from, for example, polymers such as polyester (e.g., DACRONO from E.
I. Du 17 Pont de Nemours and Company, Wilmington, DE), polypropylene, PTFE (e.g., 18 TEFLONO, E. I. Du Pont de Nemours and Company, Wilmington, DE), ePTFE
(e.g., 19 GORE-TEX from W.L. Gore & Associates, Inc., Newark, DE), PEEK, Nylon, 20 polyether-block co-polyamide polymers (e.g., PEBAXO from ATOFINA, Paris, 21 France), polyurethanes such as aliphatic polyether polyurethanes (e.g., TECOFLEXO
22 from Thermedics Polymer Products, Wilmington, MA), PVC, PAN, PS, 23 polyethersulfone, polyethylene, PMMA, thermoplastic, FEP, cellulose (e.g., 24 VISKINGO, SERVAPORO, MEMBRA-CELO, or SPECTRA/PORO 1, 3 and 6 25 Dialysis Tubing from SERVA Electrophoresis GmbH of Heidelberg, Germany;

1 Cuprophane PT- 150 from Enka-Glanstoff of Germany), such as a seamless 2 regenerated cellulose and CA, extruded collagen, silicone, echogenic, radioactive, 3 radiopaque materials or combinations thereof.

4 [01281 The barriers 128 and/or the transfer element faces 112 and/or the transfer element side 114 can be electrically charged, for example negatively charged.

6 Conductive filaments (not shown) can be sewn, fused, embedded, or otherwise 7 attached into, onto, or under the barriers 128, and/or the transfer element faces 112, 8 and/or the transfer element sides 114. The materials used to make the barriers 128, 9 and/or the transfer element faces 112, and/or the transfer element sides 114 can be embedded and/or partially or substantially coated with a conductive material.
The 11 conductive material and/or conductive filament can be statically charged before 12 deployment, and/or receive a charge from the distributor 4 and/or another energy 13 source during use. The charge on the barriers 128 and/or the transfer element faces 14 112 and/or the transfer element side 114 can repel proteins. The barriers 128 can be made from a conductive material, for example a metal. The conductive material can 16 be in electrical current communication, for example directly or inductively, with the 17 power storage device, for example the battery 60. The conductive material can 18 generate a low-level charge on the barriers 128. The low-level charge on the barriers 19 128 can repel charged particles, for example proteins.

[01291 The barriers 128 can have a barrier height 138. The barrier height 138 can 21 be from about 0 mm (0 in.) to about 10 mm (0.4 in.), more narrowly from about 1 mm 22 (0.04 in.) to about 5 mm (0.2 in.), yet more narrowly from about 2 mm (0.08 in.) to 23 about 5 mm (0.2 in.), for example about 0 mm (0 in.), about 1 mm (0.04 in.), about 2 24 mm (0.08 in.), about 5 mm (0.2 in.) or about 10 mm (0.4 in.).

1 [0130] In some embodiments of the implantable dialysis device 2, the distributor 2 valve 56 can be a one-way valve, and the implantable dialysis device 2 can have no 3 pump 54. The distributor valve 56 can have a semi-permeable membrane between the 4 internal filling port 66 and the distributor first conduit 58a.

7 [0131] Figure 16 illustrates a method for implanting the implantable dialysis device 8 2 in a recipient 140. The recipient 140 can have a peritoneal cavity 142 and a bladder 9 144. The reservoir 8 can be placed in the peritoneal cavity 142, for example in the cul-de-sac of the peritoneal cavity 142. The discharge conduit 10 (e.g., the 11 perforations 38, not shown in Figure 16) and/or the discharge conduit first port 30 can 12 be placed in the peritoneal cavity 142. The discharge conduit 10 can be placed such 13 that the discharge conduit first port 30 can be in fluid communication with the 14 peritoneal cavity 142. The exit conduit 12 can be placed across the wall of the bladder 144. The anchor 44 can be placed adjacent to and/or against the outside of 16 the bladder 144. The anchor 44 can interference fit against the outside of, or 17 otherwise be attached to, the bladder 144. The exit port 46 can be in fluid 18 communication with the inside of the bladder 144.

19 [0132] Figures 17 through 22 illustrate a method for performing dialysis using the implantable dialysis device 2. Figure 17 illustrates that the second distributor 4b can 21 be placed in a subcutaneous layer 146 between skin 148 and a muscle layer 150. The 22 second distributor 4b can be placed directly in contact with the skin 148.
The 23 internal filling port 66 can be implanted for optimized access, for example, for access 24 by a percutaneous injection. The first distributor 4a can be placed in the peritoneal cavity 142. The implantable dialysis device 2 can be tethered to the skin 148 and/or 1 subcutaneous layer 146 and/or muscle layer 150 and/or peritoneal layer 152, for 2 example, by the internal transducer connector 64 and/or part or all of the reservoir 3 conduit 6.

4 101331 The sub-anchors 98 can interference fit with the bladder 144. The sub-anchors 98 can fix the exit conduit 12 and/or the exit 14 to the bladder 144.
The 6 anchor 44 can prevent the exit 14 from moving outside of the bladder 144.
The exit 7 extension 90 can prevent the exit 14 from moving outside of the bladder 144.

8 [0134] A liquid, such as a solution of dialysate solute, another therapeutic or 9 diagnostic agent, or combinations thereof, can be inserted, as shown by arrow 154, into the internal filling port 66. The liquid in the internal filling port 66 can be 11 pumped, shown by the arrows 156, through the reservoir conduit 6 and into the 12 reservoir 8. The liquid can be pumped, for example, through the inflow channel 86.
13 The reservoir conduit 6 can pass through the first distributor 4a. The pump or pumps 14 54 (not shown) pumping the liquid to the reservoir 8 can be in the first distributor 4a and/or the second distributor 4b. The distributor valve (not shown), for example in 16 the first distributor, can be adjusted to permit flow from the internal filling port 66 to 17 the reservoir 8.

18 [0135] The reservoir 8 can be non-permeable. The reservoir conduit 6 can be non-19 permeable.

[0136] Figure 18 illustrates that an external transducer 158 can be placed adjacent to 21 and/or against the skin 148. The external transducer 158 can transfer energy to the 22 internal transducer 62. The external transducer 158 can transmit energy waves 160.
23 The energy waves 160 can be periodic magnetic fields. The energy waves can pass 24 through the skin 148 and subcutaneous layer 146. The internal transducer 62 can receive the energy waves 160. The internal transducer 62 can convert the energy 1 waves 160 into a form of energy more readily usable by the distributor. The internal 2 transducer 62 can convert the energy waves 160 from magnetic energy into electrical 3 energy. The internal transducer 62 can transmit energy via the internal transducer 4 connector 64 to the pump 54 (not shown) and/or the energy storage device (not shown).

6 [01371 Figure 19 illustrates that the first distributor 4a can pump, as shown by 7 arrows, some or all of the liquid from the reservoir 8 to the peritoneal cavity 142 8 through the reservoir conduit 6 and the discharge conduit 10. The liquid can be 9 pumped through the outflow channel 88. The distributor valve 56 can be adjusted to permit flow from the reservoir 8 to the peritoneal cavity 142. The liquid can contain 11 dissolved and/or undissolved dialysate solids 162 (i.e., dialysate solute).
The liquid 12 can decrease the osmotic pressure in the peritoneal cavity 142.

13 101381 Figure 20 illustrates that the dialysate solids 162 left in the peritoneal cavity 14 142 can draw, as shown by arrows, additional fluids and waste (e.g., toxins) across organ walls and the peritoneum (i.e., the peritoneal layer 152) and into the peritoneal 16 cavity 142.

17 101391 Figure 21 illustrates that, as shown by arrows, the pump (not shown) can 18 create pressure pulling fluids from the peritoneal cavity 142 into the discharge conduit 19 10, and through the exit conduit 12 into the bladder 144. The distributor valve 56 can be adjusted to permit flow from the peritoneal cavity 142 to the bladder 144.
When a 21 suitable amount of liquid and waste has been removed from the peritoneal cavity 142, 22 the method shown in Figure 19 can singularly or repeatedly release additional fluid 23 from the reservoir, if more fluid is desired.

24 101401 Figure 22 illustrates that the fluid in the peritoneal cavity, for example including the waste, can be drained, as shown by arrow. The bladder can be drained 1 with natural bladder evacuation (i.e., urination) and/or with a urethral (e.g., Foley) 2 catheter.

3 101411 The controller (not shown), for example in the first distributor 4a, can control 4 the energy storage device. The controller can be a processor, such as a central 5 processing unit (CPU).
6 [0142]

7 The controller can communicate data with an external controller. The first component 8 72a can have a first controller. The second component 72b can have a second 9 controller. The first controller can be in data communication with the second 10 controller. The controller can receive signals from the reservoir sensor 22, peritoneal 11 cavity sensor 36, and bladder sensor 48 by a wire or over a data network, as described 12 infra between controllers.

13 [0143] If the pressures in the peritoneal cavity 142 or the bladder 144 exceed 14 pressure thresholds levels, the controller can stop or slow the pump 54.
For example, 15 the controller can stop or slow the pump 54 if the peritoneal pressure drops below 16 about 11 mm Hg (0.21 psi), more narrowly below about 7 mm Hg (0.1 psi), yet more 17 narrowly below about 4 mm Hg (0.08 psi). The controller can stop or slow the pump 18 54 if the absolute bladder pressure rises above about 22 mm Hg (0.43 psi), yet more 19 narrowly above about 29 mm Hg (0.56 psi). The controller can stop or slow the 20 pump 54 if the differential between the peritoneal and bladder pressure rises above 21 about 15 mm Hg (0.29 psi), more narrowly above about 22 mm Hg (0.43 psi).

22 101441 The controller can stop the pump 54 and/or adjust the distributor valve 56 to 23 release the excess pressure (e.g., from the peritoneal cavity into the bladder).

24 [01451 The controller can control the distributor 4, for example including the pump 25 54 and/or the distributor valve 56. The controller can monitor the quantity and/or 1 quality (e.g., ratio of dialysate solute volume to solvent or solution volume, solution 2 temperature) of stored liquid in the implantable dialysis device 2. The controller can 3 regulate valve adjustments. The controller can regulate the distribution of fluids and 4 solutes by the implantable dialysis device 2. The controller can have a clock. The controller can control the implantable dialysis device based on the clock. For 6 example, the controller can be programmed to deliver about 100 mL (6 in.) of 7 dialysate solution from the reservoir 8 into the peritoneal cavity 142 for one-hour of 8 every six hours.

9 101461 When the implantable dialysis device 2 is low or out of stored liquid or dialysate solute, the controller can create, for example, through the distributor, a 11 vibration or other signal to indicate that the implantable liquid or dialysis device 2 is 12 low or out of stored dialysate solute.

13 [01.471 Figures 23 through 27 illustrate a method for performing dialysis using the 14 implantable dialysis device 2. The distributor 4 can be placed in the subcutaneous layer 146 adjacent to and/or against the muscle layer 150. The internal transducer 62 16 can be placed in the subcutaneous layer 146 adjacent to and/or against the skin 148.
17 The discharge conduit first port 30 and the drainage conduit first port 75 can be in the 18 peritoneal cavity 142.

19 [0148] Figure 23 illustrates that a needle and syringe 164 can be injected into the internal filling port 66. The syringe can hold liquid. Pressure can be applied, as 21 shown by arrow 166, to a plunger 167 on the syringe 164. The liquid can then enter, 22 as shown by arrow 168, the internal filling port. The distributor valve 56 can be 23 configured so the liquid can controllably flow out of the internal filling port 66.
24 101491 Figure 24 illustrates that the liquid in the internal filling port 66 can be pumped, shown by the arrows, by the distributor 4 to the reservoir 8. The distributor 1 valve 56 can be adjusted to permit flow from the internal filling port 66 to the 2 reservoir 8. The reservoir 8 can then hold the liquid. The pump (not shown) can be 3 powered using one or more methods described supra. When the distributor 4 has 4 completed pumping liquid to the reservoir conduit 6 and/or the reservoir 8, the distributor valve 56 can be adjusted to prevent flow out of the reservoir conduit 6 to or 6 through the distributor 4.

7 101501 Figure 25 illustrates that, when appropriate, the distributor 4 can pump, as 8 shown by arrows, some or all of the liquid from the reservoir 8 to the peritoneal cavity 9 142, for example, via the discharge conduit 10. The distributor valve 56 can be adjusted to permit flow from the reservoir 8 to the discharge conduit 10. The liquid 11 can be enter the peritoneal cavity 142. The liquid can have dialysate solids 162. The 12 liquid can decrease the osmotic pressure in the peritoneal cavity 142.

13 [01511 Figure 26 illustrates that dialysate solids 162 left in the peritoneal cavity 142 14 can draw, as shown by arrows, additional fluids and waste across organ walls and the peritoneum and into the peritoneal cavity 142. The additional fluids can increase the 16 fluid pressure in the peritoneal cavity 142.

17 [01521 Figure 27 illustrates that fluids in the peritoneal cavity 142 can be evacuated 18 by the peritoneal dialysis device 2. The distributor valve 56 can permit flow from the 19 drainage conduit 74 to the exit conduit 12. As shown by arrows, the pump (not shown) can create pressure pulling fluids from the peritoneal cavity 142 into the 21 drainage conduit 74, and through the exit conduit 12 into the bladder 144.
The patient 22 can dispose of fluids in the bladder 144 through urination or a catheter.
Fluids can 23 enter the drainage conduit 74 through the perforations 38, and/or the drainage conduit 24 first port 75, and/or the second discharge conduit first port guard 80a.

1 [0153] Figures 28 through 32 illustrate various methods for performing dialysis 2 using the implantable dialysis device 2 having the transfer element l 10.
Figures 28 3 and 29 illustrate various methods for introducing dialysate solids into the peritoneal 4 cavity 142. The transfer element 110 can be resiliently biased in an expanded configuration.

6 [0154] Figure 28 illustrates that a dialysate implant 170 can be placed in the 7 peritoneal cavity 142. The dialysate implant 170 can elute dialysate solids 162 in the 8 peritoneal cavity 142.

9 [0155] The dialysate implant 170 can be a solution, a gel matrix with dialysate solids, a polymer matrix with dialysate solids, made wholly of dialysate solid or 11 combinations thereof. The gel matrix with dialysate solids, polymer matrix with 12 dialysate solids, wholly dialysate solid, or combinations thereof can be formulated to 13 time-release dialysate solids. The dialysate implant 170 can be made from alginate 14 cross-linked with calcium.

[0156] The dialysate solids can be any dialysate solutes out of solution. The 16 dialysate solids can be, for example bicarbonate, dextrose, glucose, sodium, sodium 17 chloride, sodium lactate, calcium chloride, magnesium chloride, citric acid, one or 18 combinations of glucose (e.g., about 2.27% solution, MW of about 180.16), maltose, 19 such as maltose disaccharide (e.g., about 4.32% solution, MW of about 342.30), maltotriose, such as maltotriose trisaccharide (e.g., about 6.36% solution, MW
of 21 about 504.44), maltopentaose, such as maltopentaose pentasaccharide (e.g., about 22 10.4% solution, MW of about 828.72), Icodextran and/or any other osmotically active 23 material or combinations thereof.

24 [0157] Figure 29 illustrates that the distributor 4 can pump, as shown by arrows, the contents of the internal filling port 66 to the peritoneal cavity 142. The external l transducer 158 and/or an energy storage device in the implantable dialysis device 2 2 can provide the energy to pump. Placing the dialysate implant 170 in the peritoneal 3 cavity 142, as shown in Figure 28, can be performed alone or in combination with 4 pumping the contents of the internal filling port 66 to the peritoneal cavity 142 (as shown in Figure 29) and/or to the reservoir 8.

6 [0158] If the dialysate solids or solutes are introduced into the peritonea]
cavity 142, 7 the osmotic pressure in the peritoneal cavity can decrease, thereby drawing fluid, and 8 the associate waste, from the vascular system and the adjacent organs into the 9 peritoneal cavity 142. The fluid pressure in the peritoneal cavity 142 can increase. A
pressure gradient across the surface of the reservoir 8 can force fluid from the 11 peritoneal cavity 142 into the reservoir 8. The resiliency of the reservoir 8 can keep 12 the reservoir in an expanded configuration when the pressure in the peritoneal cavity 13 increases, thereby potentially creating a larger pressure gradient across the surface of 14 the reservoir 8 and potentially increasing the fluid flow rate across the surface of the reservoir 8.

16 [0159] Figure 30 illustrates that fluid in the peritoneal cavity can permeate, as 17 shown by arrows, into the transfer element 110. When fluid permeates into the 18 transfer element 110, the transfer element 110 can expand. Figure 31 illustrates that 19 particles, for example small solutes, such as urea and creatinine, can permeate, as shown by arrows, into the transfer element 110. Particles, such as proteins, can be 21 filtered from entering the transfer element 110 based on particle size and/or particle 22 charge.

23 [01601 The fluid, as shown in Figure 30, and the particles, as shown in Figure 31, 24 can concurrently permeate the transfer element 110, for example across the transfer 1 element face 112. The transfer element 110 can fill with a waste fluid, and, if used, 2 dialysate solids and/or solution.

3 [0161] Figure 32 illustrates that the distributor 4 can pump, as shown by arrow 172, 4 the waste fluid out of the reservoir 8. When the waste fluid is pumped out of the 5 transfer element 110, the transfer element 110 can remain resiliently in an expanded 6 configuration. When the waste fluid is pumped out of the transfer element 110, the 7 transfer element l 10 can resiliently contract. The distributor 4 can pump the waste 8 fluid through the discharge conduit 10. The distributor 4 can pump the waste fluid 9 through the distributor 4. The distributor 4 can pump the waste fluid through the exit 10 conduit 12. The distributor 4 can pump the waste fluid through the exit 14.
The 11 waste fluid can be pumped, as shown by arrow 174, or otherwise flow, into the 12 bladder 144.

13 101621 The transfer element 110 can be continuous emptied of waste fluids and 14 solids by the distributor 4. The transfer element 110 can be emptied of fluid by the 15 distributor 4, then the distributor 4 can wait until the transfer element 110 accumulates 16 a minimum quantity or pressure of fluid before the distributor 4 again empties the 17 transfer element 110 of fluids and solids.

18 [0163] Figure 33 illustrates a method for using the implantable dialysis device with 19 a mixing chamber 176. The discharge conduit 10 can have a pre-mix channel 178 and 20 a drainage channel 180. The mixing chamber 176 can be attached to the discharge 21 conduit first end 32a. The mixing chamber 176 can be configured to mix peritoneal 22 fluid with the dialysate or other liquid before the liquid flows from the discharge 23 conduit 10 to the peritoneal cavity 142. The mixing chamber 176 can be a perforated 24 or non-perforated chamber. The mixing chamber 176 can draw peritoneal fluid into 25 the mixing chamber. The mixing chamber 176 can then mix the peritoneal fluid with 1 the liquid (e.g., concentrated dialysate) prior to release into the peritoneal cavity 142.
2 The mixing chamber 176 can be separate from the discharge conduit 10 and/or 3 drainage conduit 74. The mixing chamber 176 can also prevent trapping the bowel or 4 other peritoneal contents in the discharge conduit first port 30 [01641 If the dialysate solution is mixed with peritoneal fluid to reduce the solute-to-6 solvent ratio of the fluid before the fluid enters the peritoneal cavity 142, the dialysate 7 solution can be held in the reservoir 8 to allow for dilution of the solute prior to 8 release into the peritonea] cavity. The discharge conduit 10 can have the pre-mix 9 channel 178 and the drainage channel 180.

[0165] Figure 34 illustrates that the internal transducer can have first and second 11 first and second magnetic poles 100a and 100b. The pole axle 102 can attach the first 12 pole 100a to the second pole 100b. The pole axle 102 can be configured to rotate 13 about the motor rotation axis 104 or be otherwise attached (e.g., via a geared 14 transmission, driveshaft, or combinations thereof) to mechanically transmit rotational force to the motor rotation axis 104. The external transducer 158 can have magnetic 16 poles offset from the first and second poles 100a and 100b of the internal transducer 17 62 (e.g., the negative pole in the external transducer 158 can align with the positive 18 pole of the internal transducer 62).

19 101661 If the poles in the external transducer 158 are rotated about the motor rotation axis 104, the first and second poles 100a and l 00b of the internal transducer 21 62 can exert a rotational force about the motor rotation axis 104 on the pole axle 102.
22 The pole axle 102 can rotate about the motor rotation axis 104. The pole axle 102 can 23 drive the flow driving mechanism (e.g., a crankshaft on the pump 54).

24 [01671 The pump 54 can drive, as shown by arrows 182, fluid flow in the reservoir conduit 6 to or from the reservoir 8. The pump 54 can drive, as shown by arrows 184, 1 fluid flow in the discharge conduit 10 from the reservoir 8 or to the distributor 4. The 2 pump 54 can drive, as shown by arrows 186, fluid flow in the exit conduit 12 to the 3 exit 14 from the distributor 4. The pump 54 can drive, as shown by arrows 188, fluid 4 flow in the internal filling port 66 to the reservoir conduit 6 or the discharge conduit 10. Fluid flow can be driven by dynamic mechanical pressure or by osmotic pressure 6 gradients.

7 [01681 Figure 35 illustrates that the distributor 4 can be placed wholly in the 8 peritoneal cavity 142. The external transducer 158 can transmit energy waves 9 into the peritoneal cavity 142. The internal transducer 62 can receive the energy waves 160. The drainage conduit 74 can be wholly within the peritoneal cavity 142.
11 [01691 Figure 36 illustrates the implantable dialysis device 2 that can have the first 12 component 72a and the second component 72b. The first component 72a can be 13 placed at a distance away from the second component 72b. The first and/or second 14 components 72a and/or 72b can have a distinct and separate internal transducer 62.
[01701 For any embodiment of the implantable dialysis device 2, the port guards 80 16 can prevent the discharge conduit ports 30, or other ports (e.g., drainage conduit ports 17 75) from being blocked by solid objects (e.g., organs and/or the dialysate implant 18 170), for example, in the peritoneal cavity 142.

19 101711 The distributor 4 can have or otherwise be in contact with the battery 60, capacitor or other energy storage device (not shown). The external transducer 21 can charge the energy storage device, for example, via the internal transducer 62. The 22 energy storage device can be used to power the distributor 4 and/or other components 23 of the implantable dialysis device 2. When the energy storage device is low on stored 24 power, a vibration or other signal, for example from the distributor, can be created to indicate that the energy storage device is low on power.

1 [0172) The patient can manually control the distributor 4, for example with the 2 external transducer 158, and/or the controller can control the internal transducer 62.
3 When the pressures, or other characteristics, sensed by the reservoir sensor 22, 4 peritoneal cavity sensor 36 and/or bladder sensor 48, are out of a predetermined range, the controller can create, for example, through the distributor, a vibration or 6 other signal to indicate that the pressures, or other characteristics, are out of a 7 predetermined range; and/or control, for example by stopping, the pump 54 and 8 distributor valve 56. The controller can shut-off the pump 54, and/or override manual 9 control, when the bladder sensor 48 reports a bladder pressure, or other characteristic, above or below a predetermined safe level. The controller can activate the pump 54, 11 and/or override manual control, when the reservoir sensor 22 reports a reservoir 12 pressure, or other characteristic, above or below a predetermined safe level.

13 [0173) A cleaning fluid, for example saline solution, can be injected, for example 14 under high pressure, into the reservoir 8 and/or transfer element 110, for example directly into the transfer element 110 and/or via the distributor 4 and/or the discharge 16 conduit 10. The cleaning fluid can exit the transfer element 110 into the peritoneal 17 cavity 142. The cleaning fluid can backwash the transfer element 110. The cleaning 18 fluid can dislodge particles, for example proteins, in the pores of the transfer element 19 110.

101741 The implantable dialysis device 2 can be used to treat and prevent congestive 21 heart failure (CHF) and high blood pressure. By draining fluid from the peritoneal 22 cavity 142, and thereby reducing the fluid pressure in the peritoneal cavity 142, the 23 implantable dialysis device 2 can induce venous fluid loss into the peritoneal cavity 24 142. This induction of venous fluid loss into the peritoneal cavity 142 can reduce venous pressure, and prevent or minimize venous fluid release in the lungs.

1 Regardless of disease state being treated, the patient can maintain hydration after 2 implantation of the implantable dialysis device 2 by drinking fluids or otherwise 3 receiving supplemental intravenous fluids.

4 [0175] It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the 6 spirit and scope of the invention. Elements shown with any embodiment are 7 exemplary for the specific embodiment and can be used on other embodiments within 8 this disclosure. Some elements have been omitted from some figures for clarity of 9 illustration, but the omission of these elements does not constitute lack of written disclosure of the use of these elements with the embodiments shown in the figures in 11 which these elements are not shown.

12 [0176] Furthermore, use of delineating nomenclature (e.g., first, second) is not 13 intended to be limiting. For example, designs and methods of use described for the 14 first and second distributors 4a and 4b can be used for the distributor 4 and vice versa.

Claims

1. An implantable peritoneal dialysis device for a subject having a peritoneal cavity and a bladder, comprising:
a pumping mechanism;
a reservoir containing a dialysate solution; and a controller operatively coupled to the pumping mechanism;
wherein the pumping mechanism, responsive to the controller, is configured to pump the dialysate solution from the reservoir into the peritoneal cavity to form a peritoneal fluid mixture, and then to pump the peritoneal fluid mixture from the peritoneal cavity to the bladder.

2. The device of Claim 1, wherein the controller further comprises a clock, the controller programmed to actuate the pumping mechanism responsive to the clock.

3. The device of Claim 1, further comprising a mixing chamber, wherein the dialysate solution comprises a concentrated dialysate solution.

4. The device of Claim 1, further comprising a sensor, wherein the sensor is configured to sense a parameter selected from the group consisting of: a pressure within the peritoneal cavity or the bladder; temperature, pH, electrolyte concentration, and analyte concentration.

5. The device of Claim 1, wherein the controller is configured to communicate data to an external controller.

6. The device of Claim 1, wherein the reservoir has an outer surface, and wherein the outer surface comprises a hydrophilic coating.

7. The device of Claim 1, further comprising an inductive recharging mechanism.

8. The device of Claim 1, further comprising a discharge conduit coupled to the pumping mechanism and which extends into the peritoneal cavity.

9. The device of Claim 8, wherein the discharge conduit further comprises a filter that restricts flow based on a particle size or a particle charge.

10. The device of Claim 8, wherein the discharge conduit further comprises a resiliently expandable transfer element configured to be disposed within the peritoneal cavity.

11. The device of Claim 1, further comprising an exit conduit coupled between the pumping mechanism and the bladder.

12. The device of Claim 11, wherein the exit conduit further comprises an anchor.

13. The device of Claim 1, further comprising a filling port operatively coupled to the reservoir.

14. The device of Claim 1, further comprising a battery coupled to the pumping mechanism.

15. The device of Claim 1, further comprising a dialysate solid containing dialysate in a time-release formulation, the dialysate solid configured to be separately implanted in the peritoneal cavity.